Femtosecond Laser-assisted Arcuate Incisions Versus Manual Arcuate Incisions Outcomes
Cataract
About this trial
This is an interventional treatment trial for Cataract focused on measuring astigmatism, limbal relaxing incisions
Eligibility Criteria
Inclusion Criteria
Subjects are eligible for the study if they meet the following criteria:
Note: Ocular criteria must be met in both eyes.
- are willing and able to understand and sign an informed consent;
- are willing and able to attend all study visits;
- are more than 40 years of age, of either gender and any race;
- are presenting for cataract surgery or refractive lens exchange with a desire to reduce astigmatism and will be implanted with a non-toric lens
- have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error and cataract)
- have 0.50 D to 1.75 D of regular corneal astigmatism
- have potential acuity of 20/25 or better
- Are scheduled to have a non-toric monofocal intraocular lens (IOL) (SN60WF) lens implanted in both eyes
Exclusion Criteria If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
- Irregular astigmatism (e.g. keratoconus)
- Corneal pathology (e.g. scar, dystrophy, pterygium, moderate-to-severe dry eye)
- Monocular status (e.g. amblyopia)
- Previous radial keratotomy, corneal refractive surgery or other corneal surgery (e.g. corneal transplant, lamellar keratoplasty)
- Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy)
- Diabetic retinopathy
- Macular pathology (e.g. age-related macular degeneration, epiretinal membrane)
- History of retinal detachment
- Subjects who have an acute or chronic disease or illness that would confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness), that are known to affect post-operative visual acuity.
Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
Sites / Locations
- Gainesville Eye Associates
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Femtosecond limbal relaxing incision (LRI)
Manual LRI
Eyes will be treated with arcuate incisions from a femtosecond laser system.
Eyes will be treated with arcuate incisions completed manually with a blade.